# FDA 483 - Choice Spine LLC - September 30, 2019

Source: https://www.globalkeysolutions.net/records/483/choice-spine-llc/bb29e972-ca86-4bff-bf99-261dabb5d317

> FDA 483 for Choice Spine LLC on September 30, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Choice Spine LLC
- Inspection Date: 2019-09-30
- Product Type: other
- Office Name: New Orleans District Office
- Summary: Choice Spine LLC, a human tissue distributor in Knoxville, TN, received an FDA Form 483 for failing to perform and document corrective actions. The firm did not address or investigate a malfunctioning freezer temperature probe, which resulted in a two-week period where proper storage conditions for distributed product could not be accurately monitored. This lapse indicates a failure in maintaining adequate quality control over product storage.

## Related Officers

- [Fabian N. Chaparro-rodriguez](https://www.globalkeysolutions.net/people/fabian-n-chaparro-rodriguez/f14fd931-0830-4a84-a287-2dd85e40195d)

Company: https://www.globalkeysolutions.net/companies/choice-spine-llc/ca35ef02-ecec-401f-a45e-ff0af0fb1033

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea
